A new report released on March 5 from the U.S. Food and Drug Administration (FDA) failed to offer a concrete plan on how the agency will regulate CBD products. Congress instructed the FDA in last year’s spending bill to adopt an enforcement discretion policy within 120 days and provide an update of its progress after 60 days. The agency missed the 60-day deadline by two weeks.
“This is more of the same from FDA: All words and no action. The longer FDA waits to regulate the CBD industry the greater chance we have of risking another public health crisis. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA).
The Council for Responsible Nutrition (CRN) also expressed its disappointment surrounding the FDA’s report.
“CRN is disheartened by today’s FDA report to Congress on CBD,” said Steve Mister, CRN’s president and CEO. “The time for ‘active consideration and evaluation’ has long since passed. As we’ve said before, the time for action was more than a year ago, but we will settle for now. Today’s report amounts to more bureaucratic can-kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient. That will direct FDA to allow CBD in dietary supplements and impose that significant regulatory framework on these products.
“Every day, more CBD products come to market, some from responsible manufacturers, and some from less reputable companies,” Mister added. “By not enforcing the full range of dietary supplement regulations on this category, FDA is essentially an absentee regulator and the public is at risk. As several recent risk assessments have demonstrated, the safety of CBD as an ingredient itself is no longer an issue. However, as long as FDA “actively” continues to drag its feet, the public is at risk from CBD products that may be poorly manufactured or illegally marketed. The best way to protect public health and promote market clarity is to give industry a clear pathway to market.”
FDA Commissioner Stephen M. Hahn, MD also released a separate statement regarding the potential risks of CBD, noting that “We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals—and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.
“But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA. We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”
